Diabetes
Conditions
Interventions
Aggressive antiglycaemic therapy is to be administered by using sitagliptin
Sponsors
Saga lifestyle related disease treatment study group secretariat
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Type 2 diabetes patients diagnosed according to the clinical diagnostic criteria of the Japan Diabetes Society 2) Patients aged >=20 years 3) Patients who fully understand the study procedures and have given written informed consent on use of their data for the study
Exclusion criteria
Exclusion criteria: 1) Patient with a history of severe ketosis, diabetic coma or pre-coma within the past 6 months 2) Patient with severe infection, a recent history of surgery, and those who are scheduled to undergo surgery soon, or serious external wound 3) Pregnant patients, including one trying to conceive pregnancy during the planned study period, and breast-feeding patients 4) Patients with modest to severe renal impairment (creatinine clearance >=30 mL/min; serum creatinine >=1.5mg/dL in men and >=1.3mg/dL in women) 5) Patients with a history of hypersensitivity to the study agent 6) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change and % change in HbA1c at 3 months after study initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change and % change in HbA1c (excluding values at 3 months), HOMA-beta, TC, HDL-C, TG and body weight at 3, 6, 9 and 12 months after study initiation - Change and % change in EQ5D and PSQI scores at 3 and 12 months after study initiation | — |
Countries
Japan
Contacts
Public ContactJunichi Oyama
Saga lifestyle related disease treatment study group secretariat
Outcome results
None listed